FDA Revises List of Recognized Standards

(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration (FDA) has issued new revisions to its list of accepted standards for use in pre-market reviews of medical devices. The FDA Modernization Act of 1997 authorized the agency to recognize voluntary consensus standards developed in an open and transparent process.

“Modifications to the List of Recognized Standards, Recognition List Number: 020” will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. The list contains both modified existing standards and new additions to the accepted standards. A total of 32 documents were added to the list in the fields of biocompatibility; cardiovascular/neurology; dental, ear, nose, and throat; general hospital, general plastic surgery; in vitro diagnostic; materials; OB-GYN, gastroenterology; ophthalmic; physical medicine; and sterility.

To see the complete list of modified and additional standards, visit http://edocket.access.gpo.gov/2008/E8-20939.htm.

For further information, visit www.ansi.org/news_publications/news_story.aspx?menuid=7&articleid=1961.

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